Comparative Assessment of Safety and Efficacy of Mono and Dual Anti-platelet therapy in Coronary Artery Disease patients: A Prospective Cohort Study in a Tertiary care Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Efficacy – Clinical Outcomes, Patient reported outcomes
研究概览
简要总结
Riskof bleeding and other ADRs associated with antiplatelet therapy are welldocumented, but most data comes from clinical trials with strict inclusioncriteria. There is insufficient evidence on Incidence, severityand causality of Adverse Drug Reactions in a Heterogeneous population over aprolonged period, especially in a tertiary care setting.
Investigatingtherapy transitions have not been thoroughly explored in past studies. Thereis lack of comprehensive data on Medication Related Problems inpatients receiving Mono and Dual antiplatelet therapies, particularly regardinghow these problems evolve and impact the long term therapy outcomes. Patientson antiplatelet therapy are at risk of medication related problems, which canlead to suboptimal therapeutic outcomes, increased morbidity and higher healthcare costs. Systematic identification and analysis of these problems can help inoptimizing therapy and improving patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients Diagnosed with CAD receiving antiplatelet therapy (IPD & OPD) Patients aged 18 years and older of both sexes.
- •Patients who provide informed consent to participate in the study.
排除标准
- •Patients with known contraindications to antiplatelet therapy, such as active bleeding disorders.
- •Patients with severe co morbid conditions that could confound study outcomes (Advanced liver disease, several renal impairment, malignancies).
- ••Patients who have undergone major surgery within the last 3 months.
- •Pregnant or breastfeeding women.
- •Patients with terminal illness whose life expectancy is less than 1 year.
结局指标
主要结局
Efficacy – Clinical Outcomes, Patient reported outcomes
时间窗: Baseline, 03 Months, 06 Months, and 12 Months
Safety – Bleeding events, Adverse Drug reactions, All cause mortality
时间窗: Baseline, 03 Months, 06 Months, and 12 Months
次要结局
- QoL – WHO BREF(Cost analysis – Direct & Indirect costs)